Label: NOVAREL- gonadotrophin, chorionic kit

  • NDC Code(s): 55566-1501-1, 55566-1502-1, 55566-1700-0
  • Packager: Ferring Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated April 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence.

    NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days.

    Each 5,000 USP units vial contains:

    chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.

    Each 10,000 USP units vial contains:

    chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.

  • CLINICAL PHARMACOLOGY

    The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone. Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present. This descent is usually reversible when HCG is discontinued. During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function.

    During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone, and preventing menstruation. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.

  • INDICATIONS AND USAGE

    HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.

    1. Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9.
    2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
    3. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.
  • CONTRAINDICATIONS

    Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman. Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.

  • WARNINGS

    HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions during this use are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion; (2) Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum; (3) Multiple births, and (4) Arterial thromboembolism.

    The recommended diluent for reconstitution is Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

    Anaphylaxis has been reported with urinary-derived HCG products.

  • PRECAUTIONS

    General

    1. Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.
    2. Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.

    Drug/Laboratory test

    HCG can crossreact in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of crossreactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    There have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility. A causative relationship between HCG and tumor development in these men has not been established. Defects of forelimbs and of the central nervous system, as well as alterations in sex ratio, have been reported in mice on combined gonadotropin and HCG regimens. The dose of gonadotropin used was intended to induce superovulation. No mutagenic effect has been clearly established in humans. Fertility—see "INDICATIONS AND USAGE."

    Pregnancy

    See "CONTRAINDICATIONS" section. Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HCG is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in children below the age of 4 have not been established.

  • ADVERSE REACTIONS

    (see WARNINGS) Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.

  • DOSAGE AND ADMINISTRATION

    (Intramuscular Use Only): The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient, and the physician's preference. The following regimens have been advocated by various authorities.

    Prepubertal cryptorchidism not due to anatomical obstruction:

    (1)
    4,000 USP Units three times weekly for three weeks.
    (2)
    5,000 USP Units every second day for four injections.
    (3)
    15 injections of 500 to 1,000 USP Units over a period of six weeks.
    (4)
    500 USP Units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later, giving 1,000 USP Units per injection.

    Selected cases of hypogonadotropic hypogonadism in males:

    (1)
    500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks.
    (2)
    4,000 USP Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP Units three times weekly for an additional three months.
    Table 1. Final Concentration after Reconstitution
    Reconstitution volume of bacteriostatic water for injection10,000 IU Vial Concentration5,000 IU Vial ConcentrationAdministration
    1 mL10,000 IU/mL5,000 IU/mLAdminister entire dose at once
    10 mL1,000 IU/mL500 IU/mLMultiple dose administration, refrigerate between doses

    NOTE: Prior to diluting NOVAREL with Bacteriostatic Water for Injection (Table 1):

    • Remove the flip caps off the vial of bacteriostatic water and the vial of NOVAREL
    • Wipe the tops of the vials with an alcohol pad or alcohol soaked gauze
    • Do not touch the tops of the vials after you wipe them.

    Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins (See prescribing information for menotropins for dosage and administration for that drug product).

    5,000 to 10,000 USP Units one day following the last dose of menotropins. (A dosage of 10,000 USP Units is recommended in the labeling for menotropins).

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    Disposing of Needles and Syringes

    To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container. Sharps containers should then be taken to a collection center for proper disposal. Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps.

    In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins. Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.

  • HOW SUPPLIED

    NOVAREL (chorionic gonadotropin) for Injection, USP, is available as individually packaged multiple-dose vials containing 5,000 or 10,000 USP Units per vial.

    Each vial of NOVAREL is accompanied by a vial of sterile diluent containing 10 mL of Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol.

    NOVAREL is available in the following presentations:

    • NDC 55566-1501-1: 10,000 USP units of chorionic gonadotropin injection in 1 vial with blue cap and 1 vial of diluent
    • NDC 55566-1502-1: 5,000 USP units of chorionic gonadotropin injection in 1 vial with aqua cap and 1 vial of diluent

    Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature].

    REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Ferring Pharmaceuticals Inc.

    Parsippany, NJ 07054
    U.S. License No. 2112

    XXXXXXXXXX

    Rev. 05/2023

  • PRINCIPAL DISPLAY PANEL - Kit Carton - 10,000 USP

    NDC 55566-1501-1
    Rx only

    chorionic gonadotropin

    Novarel®

    for injection
    10,000 USP units
    for intramuscular use only

    1 multiple-dose vial of Chorionic Gonadotropin
    for Injection

    1 multiple-dose vial of
    Bacteriostatic Water
    for injection, USP, 10 mL

    FERRING
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - Kit Carton - 10,000 USP
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 5,000 USP

    NDC 55566-1502-1
    Rx only

    chorionic gonadotropin

    Novarel®

    for injection
    5,000 USP units
    for intramuscular use only

    1 multiple-dose vial of Chorionic Gonadotropin
    for Injection

    1 multiple-dose vial of
    Bacteriostatic Water
    for injection, USP, 10 mL

    FERRING
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - Kit Carton - 5,000 USP
  • INGREDIENTS AND APPEARANCE
    NOVAREL 
    gonadotrophin, chorionic kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55566-1501
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55566-1501-11 in 1 CARTON01/15/197410/31/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL
    Part 21 VIAL 10 mL
    Part 1 of 2
    NOVAREL 
    gonadotrophin, chorionic injection, powder, lyophilized, for solution
    Product Information
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHORIONIC GONADOTROPIN (UNII: 20ED16GHEB) (CHORIONIC GONADOTROPIN - UNII:20ED16GHEB) CHORIONIC GONADOTROPIN10000 [USP'U]
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA01701601/15/1974
    Part 2 of 2
    BACTERIOSTATIC WATER 
    water solution
    Product Information
    Item Code (Source)NDC:55566-1700
    Route of AdministrationINTRAMUSCULAR
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55566-1700-010 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA01701601/15/1974
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA01701601/15/197410/31/2021
    NOVAREL 
    gonadotrophin, chorionic kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55566-1502
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55566-1502-11 in 1 CARTON08/30/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL
    Part 21 VIAL 10 mL
    Part 1 of 2
    NOVAREL 
    gonadotrophin, chorionic injection, powder, lyophilized, for solution
    Product Information
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHORIONIC GONADOTROPIN (UNII: 20ED16GHEB) (CHORIONIC GONADOTROPIN - UNII:20ED16GHEB) CHORIONIC GONADOTROPIN5000 [USP'U]
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA01701608/30/2017
    Part 2 of 2
    BACTERIOSTATIC WATER 
    water solution
    Product Information
    Item Code (Source)NDC:55566-1700
    Route of AdministrationINTRAMUSCULAR
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55566-1700-010 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA01701601/15/1974
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA01701608/30/2017
    Labeler - Ferring Pharmaceuticals Inc. (103722955)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferring Production Inc.079510999manufacture(55566-1502) , pack(55566-1502, 55566-1501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jubilant HollisterStier General Partnership246762764manufacture(55566-1501, 55566-1502) , pack(55566-1501, 55566-1502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferring GmbH328609615manufacture(55566-1501) , pack(55566-1501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferring International Center SA481210362pack(55566-1501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen Oss B.V.491017488api manufacture(55566-1501, 55566-1502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen Oss B.V.491013870api manufacture(55566-1501, 55566-1502)
    Establishment
    NameAddressID/FEIBusiness Operations
    F.M. Howell & Company962888116pack(55566-1501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Instituto Massone S.A.970053831api manufacture(55566-1501, 55566-1502)